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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013980
Receipt No. R000016289
Scientific Title Efficacy evaluation of Tiotropium Respimat with AeroChamber Plus
Date of disclosure of the study information 2014/05/17
Last modified on 2016/06/01

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Basic information
Public title Efficacy evaluation of Tiotropium Respimat with AeroChamber Plus
Acronym Inhalation therapy using Tiotropium Respimat with AeroChamber Plus
Scientific Title Efficacy evaluation of Tiotropium Respimat with AeroChamber Plus
Scientific Title:Acronym Inhalation therapy using Tiotropium Respimat with AeroChamber Plus
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficay of Tiotropium Respimat with AeroChamber Plus on lung function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Change of forced expiratory volume in 1 second (FEV1) after inhalation therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Inhalation of Tiotropium Respimat with AeroChamber Plus
Interventions/Control_2 Inhalation of Tiotropium Respimat without AeroChamber Plus
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients >= 20 years of age with a diagnosis of stage 1 - 3 COPD.
2. Patients continuing use of tiotropium respimat.
3. Patients planning to start tiotropium respimat.
4. Patients who are not using long acting be-ta 2-agonist (LABA) or inhaled corticosteroid (ICS)/LABA combination.
Key exclusion criteria 1. Known severe allergy to any drugs.
2. Patients with benign prostatic hypertrophy or glaucoma.
3. Patients who cannot parchase AeroChamber Plus.
4. Patients who cannot use tiotropium respimat with inhalation assistance.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Ogasawara
Organization Hamamatsu Medical Center
Division name The department of respiratory medicine
Zip code
Address 328 Tomitsuka, Hamamatsu, Shizuoka
TEL 053-453-7111
Email shikatarawasagao@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Ogasawara
Organization Hamamatsu Medical Center
Division name Department of respiratory medicine
Zip code
Address 328 Tomitsuka, Hamamatsu, Shizuoka
TEL 053-453-7111
Homepage URL
Email shikatarawasagao@gmail.com

Sponsor
Institute Hamamatsu medical center
Institute
Department

Funding Source
Organization Non
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 17 Day
Last modified on
2016 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016289

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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